Under accelerated review status, the FDA approves Epizyme’s (EPZM +4.5%)
Tazverik (tazemetostat) for the treatment of adult patients with
relapsed/refractory follicular lymphoma (FL) whose tumors are positive
for an EZH2 mutation as detected by an FDA-approved test and who have
received at least two prior systemic therapies and adults with
relapsed/refractory FL who have no realistic treatment options.
Accelerated approval stipulates certain
post-marketing requirements including a confirmatory study to validate
the treatment benefits.
The FDA approved the methyltransferase inhibitor in January for epithelioid sarcoma.
https://seekingalpha.com/news/3584282-fda-oks-epizymes-tazemetostat-for-treatment-resistant-follicular-lymphoma
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